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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: similar or equivalent to OECD TG 401: LD50 > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-GLP study, similar to OECD TG 401, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
test was done before GLP came into force
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Observation period: 14 days
- Frequency of observations: daily
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 of 10 rats was observed dead at day 2.
Clinical signs:
other: Slight lethargy
Interpretation of results:
other: Not Classified
Remarks:
Criteria not met according to EU CLP 1272/2008 and its amendments
Conclusions:
The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw. Therefore the substance does not need to be classified according to GHS.
Executive summary:

Acute oral toxicity: In this study, 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Slight lethargy was observed and one of ten rats was observed dead at day two. The acute oral LD50 for the substance was determined to be > 5000 mg/kg bw. Therefore the substance does not need to be classified for acute oral toxicity according to EU CLP 1272/2008 and its amendments.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity: In this study, 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Slight lethargy was observed and one of ten rats was observed dead at day two. The acute oral LD50 for the substance was determined to be > 5000 mg/kg bw.

In addition, also an acute dermal toxicity study (similar to OECD TG 402) is available with an LD50 in rabbits of > 5000 mg/kg bw, not indicating an impact on the classification and therefore not included in detail.

Justification for classification or non-classification

The substance does not have to be classified for acute oral toxicity according to the criteria outlined in EU CLP (1272/2008/EC and its amendments).